PERTZYE- pancrelipase capsule, delayed release
Digestive Care, Inc.
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HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use PERTZYE safely and effectively. See full prescribing information for PERTZYE.
PERTZYE (pancrelipase) delayed-release capsules, for oral use Initial U.S. Approval: 2012 INDICATIONS AND USAGEPERTZYE® is indicated for the treatment of exocrine pancreatic insufficiency in adult and pediatric patients. (1) DOSAGE AND ADMINISTRATIONImportant Dosing Information (2.1)
Recommended Dosage (2.2) Adults and Pediatric Patients Greater than 12 Months: The recommended initial starting dosage is:
Pediatric Patients Birth to 12 Months: The recommended dosage is 4,000 lipase units (one capsule) per 120 mL of formula or per breastfeeding. Preparation and Administration Instructions (2.3)
DOSAGE FORMS AND STRENGTHSDelayed-Release Capsules (3):
CONTRAINDICATIONSNone. (4) WARNINGS AND PRECAUTIONS
ADVERSE REACTIONSMost common adverse reactions (≥ 10%) are: diarrhea, dyspepsia, and cough. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Digestive Care Inc. at 1-877-882-5950 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. See 17 for PATIENT COUNSELING INFORMATION and Medication Guide. Revised: 2/2024 |
PERTZYE® is indicated for the treatment of exocrine pancreatic insufficiency in adult and pediatric patients.
PERTZYE is a mixture of enzymes including lipases, proteases, and amylases. PERTZYE dosing is based on lipase units.
Adults and Pediatric Patients Greater than 12 Months of Age
The recommended oral initial starting dosage is:
If signs and symptoms of malabsorption persist, increase the dosage. Titrate to either 2,500 lipase units/kg/meal, 10,000 lipase units/kg/day, or 4,000 lipase units/gram of fat ingested/day. Higher dosages may be administered if they are documented to be effective by fecal fat measures or an improvement in signs or symptoms of malabsorption including measures of nutritional status.
Adult and Pediatric Patients Greater than 12 Months of Age
Instruct adult and pediatric patients greater than 12 months of age, or their caregivers, of the following:
Oral Administration for Patients Unable to Swallow Intact Capsules
Gastrostomy Tube Administration (14 French Gastrostomy Tube or Larger)
Pediatric Patients Birth to 12 Months of Age:
Instruct caregivers of pediatric patients birth to 12 months of age of the following:
Delayed-release capsules are available in the following strengths:
Fibrosing colonopathy has been reported following treatment with pancreatic enzyme products. Fibrosing colonopathy is a rare, serious adverse reaction initially described in association with use of high-dose pancreatic enzyme products, usually with use over a prolonged period of time and most commonly reported in pediatric patients with cystic fibrosis. Pancreatic enzyme products exceeding 6,000 lipase units/kg/meal have been associated with colonic stricture, a complication of fibrosing colonopathy, in pediatric patients less than 12 years of age. The underlying mechanism of fibrosing colonopathy remains unknown.
If there is a history of fibrosing colonopathy, monitor patients during treatment with PERTZYE because some patients may be at risk of progressing to colonic stricture formation. It is uncertain whether regression of fibrosing colonopathy occurs. Do not exceed the recommended dosage of either 2,500 lipase units/kg/meal, 10,000 lipase units/kg/day, or 4,000 lipase units/g fat ingested/day in adult and pediatric patients greater than 12 months of age without further investigation. Higher dosages may be administered if they are documented to be effective by fecal fat measures or an improvement in signs and symptoms of malabsorption including measures of nutritional status. Patients receiving dosages higher than 6,000 lipase units/kg/meal should be frequently monitored for symptoms of fibrosing colonopathy and the dosage decreased or titrated downward to a lower range if clinically appropriate [see Dosage and Administration (2.1)].
Crushing or chewing PERTZYE capsules or mixing the capsule contents in foods having a pH greater than 4.5 can disrupt the protective enteric coating on the capsule contents and result in early release of enzymes, irritation of the oral mucosa, and/or loss of enzyme activity.
Instruct the patient or caregiver of the following:
Pancreatic enzyme products contain purines that may increase blood uric acid levels. High dosages have been associated with hyperuricosuria and hyperuricemia [see Overdosage (10)]. Consider monitoring blood uric acid levels in patients with gout, renal impairment, or hyperuricemia during treatment with PERTZYE.
PERTZYE is sourced from pancreatic tissue from swine used for food consumption. Although the risk that PERTZYE will transmit an infectious agent to humans has been reduced by testing for certain viruses during manufacturing and by inactivating certain viruses during manufacturing, there is a theoretical risk for transmission of viral disease, including diseases caused by novel or unidentified viruses. Thus, the presence of porcine viruses that might infect humans cannot be definitely excluded. However, no cases of transmission of an infectious illness associated with the use of porcine pancreatic extracts have been reported.
Severe hypersensitivity reactions including anaphylaxis, asthma, hives, and pruritus have been reported with pancreatic enzyme products [see Adverse Reactions (6.2)]. If symptoms occur, initiate appropriate medical management.
Monitor patients with a known hypersensitivity reaction to proteins of porcine origin for hypersensitivity reactions during treatment with PERTZYE. The risks and benefits of continued PERTZYE treatment in patients with severe hypersensitivity reactions should be taken into consideration with the overall clinical needs of the patient.
The following serious or otherwise important adverse reactions are described elsewhere in the labeling:
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to the rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
The data described below reflect exposure to PERTZYE in 21 patients, aged 8 to 43 years, with exocrine pancreatic insufficiency due to cystic fibrosis in a placebo-controlled clinical trial [see Clinical Studies (14)].
Table 1 enumerates adverse reactions that occurred in at least 2 patients (greater than or equal to 10%) treated with PERTZYE at a higher rate than with placebo.
Adverse Reaction | PERTZYE N=21 (%) | Placebo N=24 (%) |
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Diarrhea | 10% | 4% |
Dyspepsia | 10% | 4% |
Cough | 10% | 4% |
The following adverse reactions have been identified during post-approval use of PERTZYE or other pancreatic enzyme products. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Eye Disorders
Gastrointestinal Disorders
Immune System Disorders
Investigations
Musculoskeletal System
Skin and Subcutaneous Tissue Disorders
Risk Summary
Published data from case reports with pancrelipase use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. Pancrelipase is minimally absorbed systematically; therefore, maternal use is not expected to result in fetal exposure to the drug. Animal reproduction studies have not been conducted with pancrelipase.
The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
Risk Summary
There are no data on the presence of pancrelipase in either human or animal milk, the effects on the breastfed infant or the effects on milk production. Pancrelipase is minimally absorbed systemically following oral administration, therefore maternal use is not expected to result in clinically relevant exposure of breastfed infants to the drug. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for PERTZYE and any potential adverse effects on the breastfed infant from PERTZYE or from the underlying maternal condition.
The safety and effectiveness of PERTZYE for the treatment of exocrine pancreatic insufficiency have been established in pediatric patients.
Use of PERTZYE for this indication is supported by a randomized, double-blind, placebo-controlled, crossover study of 24 pediatric patients, 8 years and older with exocrine pancreatic insufficiency due to cystic fibrosis. The safety in pediatric patients was similar to that observed in adult patients [see Adverse Reactions (6.1) and Clinical Studies (14)].
Dosages exceeding 6,000 lipase units/kg/meal have been reported postmarketing to be associated with fibrosing colonopathy and colonic strictures in pediatric patients less than 12 years of age. If there is a history of fibrosing colonopathy, monitor patients during treatment with PERTZYE because some patients may be at risk of progressing to stricture formation. Do not exceed the recommended dosage of either 2,500 lipase units/kg/meal, 10,000 lipase units/kg/day, or 4,000 lipase units/g fat ingested/day in pediatric patients greater than 12 months of age without further investigation [see Dosage and Administration (2.1) and Warnings and Precautions (5.1)].
Crushing or chewing PERTZYE capsules or mixing the capsule contents in foods having a pH greater than 4.5 can disrupt the protective enteric coating on the capsule contents and result in early release of enzymes, irritation of the oral mucosa, and/or loss of enzyme activity. Instruct the patient or caregiver of the following: consume sufficient liquids (juice, water, breast milk, or formula) to ensure complete swallowing, and visually inspect the mouth of pediatric patients less than 12 months of age to ensure that no drug is retained in the mouth and irritation of the oral mucosa has not occurred [see Dosage and Administration (2.3) and Warnings and Precautions (5.2)].
Clinical studies of PERTZYE did not include sufficient numbers of patients aged 65 years and over to determine whether they respond differently from younger patients. Other reported clinical experience has not identified differences in responses between patients aged 65 years and over and younger adult patients.
Chronic high dosages of pancreatic enzyme products have been associated with fibrosing colonopathy and colonic strictures [see Warnings and Precautions (5.1)]. High dosages of pancreatic enzyme products have been associated with hyperuricosuria and hyperuricemia [see Warnings and Precautions (5.3)].
Pancrelipase is a pancreatic enzyme product consisting of a mixture of enzymes including lipases, proteases, and amylases, and is an extract derived from porcine pancreatic glands. The enteric-coated microspheres in PERTZYE are formulated to release pancreatic enzymes at an approximate pH of 5.5 or greater.
PERTZYE (pancrelipase) delayed-release capsules are for oral administration, include a two-piece hard gelatin shell containing light tan/cream-colored bicarbonate-buffered enteric-coated microspheres ranging in size from 0.8 to 1.4 mm in diameter for 4,000 USP units of lipase and 0.8 to 2.2 mm in diameter for 8,000, 16,000, and 24,000 USP units of lipase, and are available as follows:
4,000 USP units of lipase; 14,375 USP units of protease; and 15,125 USP units of amylase; delayed-release capsules have a clear body printed in green with "4" and a clear cap printed with a green circular stripe and "DCI". The imprinting ink on the capsule contains FD&C Blue #1, D&C Yellow #10, black iron oxide, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, shellac, and ammonium hydroxide.
8,000 USP units of lipase; 28,750 USP units of protease; and 30,250 USP units of amylase; delayed-release capsules have a clear body printed in blue with "8" and a clear cap printed with a blue circular stripe and "DCI". The imprinting ink on the capsule contains FD&C Blue #1, ethanol, methanol, n-butyl alcohol, propylene glycol, shellac, and ammonium hydroxide.
16,000 USP units of lipase; 57,500 USP units of protease; and 60,500 USP units of amylase; delayed-release capsules have a clear body printed in red with "16" and a clear cap printed with a red circular stripe and "DCI". The imprinting ink on the capsule contains FD&C Red #40, povidone, titanium dioxide, dehydrated alcohol, sodium hydroxide, butyl alcohol, propylene glycol, isopropyl alcohol, and shellac.
24,000 USP units of lipase; 86,250 USP units of protease; and 90,750 USP units of amylase; delayed-release capsules have a clear body printed in purple with "24" and a clear cap printed with a purple circular stripe and "DCI". The imprinting ink on the capsule contains FD&C Blue #2, D&C Red #7, titanium dioxide, strong ammonia solution, propylene glycol, butyl alcohol, isopropyl alcohol, dehydrated alcohol, and shellac.
PERTZYE (pancrelipase) delayed-release capsules include the following inactive ingredients: cellulose acetate phthalate, diethyl phthalate, polyvinylpyrrolidone, sodium bicarbonate, sodium carbonate, sodium starch glycolate, talc, and ursodiol.
Pancreatic enzyme products contain a mixture of lipases, proteases, and amylases that catalyze the hydrolysis of fats to monoglyceride, glycerol and free fatty acids, proteins into peptides and amino acids, and starches into dextrins and short chain sugars such as maltose and maltotriose in the duodenum and proximal small intestine, thereby acting like digestive enzymes physiologically secreted by the pancreas.
For patients consuming a high fat diet in the clinical trials, the coefficient of fat absorption (CFA) was higher in patients who received PERTZYE compared to the placebo treatment group, indicating improved fat absorption [see Clinical Studies (14)].
Adult and Pediatric Patients
A randomized, double-blind, placebo-controlled, crossover study was conducted in 24 patients aged 8 to 43 years (mean age of 20 years) with exocrine pancreatic insufficiency due to cystic fibrosis. Patients were randomized to receive PERTZYE at individually titrated doses (not to exceed 2,500 lipase units/kg/meal) or matching placebo for 6 to 8 days of treatment, followed by crossover to the alternate treatment for an additional 6 to 8 days. The mean lipase dosage during the treatment period was 1,565 lipase units/kg/meal and a controlled high-fat diet (approximately 2g fat/kg/day) was maintained throughout the study. The length of exposure to PERTZYE during this study was 20 to 28 days, including the treatment period of 6 to 8 days, and the open label titration and transition periods of 7 to 10 days each.
The efficacy analysis population included 21 patients who completed both double-blind treatment periods.
Coefficient of Fat Absorption Endpoint and Results
The primary efficacy endpoint was the mean difference in coefficient of fat absorption (CFA) between PERTZYE and placebo treatment. The CFA was determined by a 72-hour stool collection during both treatments, when both fat ingestion and excretion were measured.
Mean CFA was 83% with PERTZYE treatment compared to 46% with placebo treatment. The mean difference in CFA was 36 percentage points in favor of PERTZYE treatment with 95% CI: (28, 45) and p<0.001.
Coefficient of Nitrogen Absorption Endpoint and Results
The coefficient of nitrogen absorption (CNA) was determined by a 72-hour stool collection during both treatments, when nitrogen excretion was measured and nitrogen ingestion from a controlled diet was estimated (based on the assumption that proteins contain 16% nitrogen). Each patient's CNA during placebo treatment was used as their no-treatment CNA value.
Mean CNA was 79% with PERTZYE treatment compared to 47% with placebo treatment. The mean difference in CNA was 32 percentage points in favor of PERTZYE treatment and this was a statistically significant change.
There were no differences between pediatric patients and adults in the severity of pancreatic insufficiency (placebo response) or in the magnitude of the response to PERTZYE.
PERTZYE (pancrelipase) delayed-release capsules, containing light tan/cream-colored delayed-release microspheres are supplied as follows:
Strength | Description | Supplied As | NDC Number |
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4,000 USP units of lipase; 14,375 USP units of protease; 15,125 USP units of amylase | Two-piece hard gelatin capsule with a clear body printed in green with "4" and a clear cap printed with a green circular stripe and "DCI" | Bottles of 100 | 59767-004-01 |
8,000 USP units of lipase; 28,750 USP units of protease; 30,250 USP units of amylase | Two-piece hard gelatin capsule with a clear body printed in blue with "8" and a clear cap printed with a blue circular stripe and "DCI" | Bottles of 100 Bottles of 250 | 59767-008-01 59767-008-02 |
16,000 USP units of lipase; 57,500 USP units of protease; 60,500 USP units of amylase | Two-piece hard gelatin capsule with a clear body printed in red with "16" and a clear cap printed with a red circular stripe and "DCI" | Bottles of 100 Bottles of 250 | 59767-016-01 59767-016-02 |
24,000 USP units of lipase; 86,250 USP units of protease; 90,750 USP units of amylase | Two-piece hard gelatin capsule with a clear body printed in purple with "24" and a clear cap printed with a purple circular stripe and "DCI" | Bottles of 80 Bottles of 200 | 59767-024-01 59767-024-02 |
Storage and Handling
Advise the patient or caregiver to read the FDA-approved patient labeling (Medication Guide and Instructions for Use).
Fibrosing Colonopathy
Advise the patient or caregiver that fibrosing colonopathy has been reported with high dosages of pancreatic enzyme products, usually with use over a prolonged period of time and in pediatric patients less than 12 years of age. Advise patients and caregivers that if signs and symptoms of colon stricture formation occur (e.g., stomach area (abdominal) pain, bloating, trouble passing stool (constipation), nausea, vomiting, diarrhea) to immediately contact their healthcare provider [see Warnings and Precautions (5.1)].
Hyperuricemia
Advise the patient or caregiver that hyperuricemia may occur in patients with gout or renal impairment and to contact the healthcare provider if they experience pain, stiffness, redness or swelling of their joints [see Warnings and Precautions (5.3)].
Hypersensitivity Reactions
Inform the patient or caregiver that severe hypersensitivity reactions, including anaphylaxis, asthma, hives, and pruritus, have been reported with use of pancreatic enzyme products. Seek medical attention if signs or symptoms of a hypersensitivity reaction develop [see Warnings and Precautions (5.5)].
Dosage
Advise the patient or caregiver to take or administer PERTZYE as prescribed, and to contact the healthcare provider if signs and symptoms of malabsorption persist [see Dosage and Administration (2.2)].
Administration
Instruct the patient or caregiver to:
Manufactured by:
Digestive Care, Inc.
1120 Win Drive
Bethlehem, PA 18017
U.S. License No. 2184
Product of USA
PERTZYE® is a registered trademark of Digestive Care, Inc.
U.S. Patent Numbers: 5,260,074; 5,302,400; 5,324,514; 5,460,812; 5,578,304; 5,750,104
This Medication Guide has been approved by the U.S. Food and Drug Administration. | Revised: 02/2024 | ||
MEDICATION GUIDE PERTZYE (pert-zye) (pancrelipase) delayed-release capsules |
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What is the most important information I should know about PERTZYE?
PERTZYE may increase the risk of having a rare bowel disorder called fibrosing colonopathy, especially if taken at a high dose for a long time in children with cystic fibrosis. This condition is serious and may require surgery. The risk of having this condition may be reduced by following the dosing instructions that your doctor gives you. Call your doctor right away if you have any unusual or severe: |
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Take PERTZYE exactly as prescribed by your doctor. Do not take more PERTZYE than directed by your doctor. | |||
What is PERTZYE?
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Before taking PERTZYE, tell your doctor about all of your medical conditions, including if you:
Know the medicines you take. Keep a list of them and show it to your doctor and pharmacist when you get a new medicine. |
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How should I take PERTZYE?
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What are the possible side effects of PERTZYE?
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The most common side effects of PERTZYE include: | |||
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Other possible side effects:
PERTZYE and other pancreatic enzyme products are made from the pancreas of pigs, the same pigs people eat as pork. These pigs may carry viruses. Although it has never been reported, it may be possible for a person to get a viral infection from taking pancreatic enzyme products that come from pigs. Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects of PERTZYE. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. |
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How should I store PERTZYE?
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General information about the safe and effective use of PERTZYE.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use PERTZYE for a condition for which it was not prescribed. Do not give PERTZYE to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or doctor for information about PERTZYE that is written for health professionals. |
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What are the ingredients in PERTZYE?
Active ingredients: lipase, protease, and amylase. Inactive ingredients: cellulose acetate phthalate, diethyl phthalate, polyvinylpyrrolidone, sodium bicarbonate, sodium carbonate, sodium starch glycolate, talc, and ursodiol. The hard gelatin capsule shells contain: gelatin and water. The green imprinting ink on the 4,000 units of lipase; 14,375 units of protease; 15,125 units of amylase capsules contain: FD&C Blue #1, D&C Yellow #10, black iron oxide, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, shellac and ammonium hydroxide. The blue imprinting ink on the 8,000 units of lipase; 28,750 units of protease; 30,250 units of amylase capsules contain: FD&C Blue #1, ethanol, methanol, n-butyl alcohol, propylene glycol, shellac and ammonium hydroxide. The red imprinting ink on the 16,000 units of lipase; 57,500 units of protease; 60,500 units of amylase capsules contain: FD&C Red #40, povidone, titanium dioxide, dehydrated alcohol, sodium hydroxide, butyl alcohol, propylene glycol, isopropyl alcohol, and shellac. The purple imprinting ink on the 24,000 units of lipase; 86,250 units of protease; 90,750 units of amylase capsules contain: FD&C Blue #2, D&C Red #7, titanium dioxide, strong ammonia solution, propylene glycol, butyl alcohol, isopropyl alcohol, dehydrated alcohol, and shellac. For more information, go to www.Pertzye.com or call 1-877-882-5950. |
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Manufactured by:
Digestive Care, Inc. 1120 Win Drive Bethlehem, PA 18017 U.S. License No. 2184 Product of USA |
INSTRUCTIONS FOR USE
PERTZYE (pert-zye)
(pancrelipase)
delayed-release capsules
This Instructions for Use contains information on how to give PERTZYE by mouth and through a gastrostomy tube.
Important Information You Need to Know Before Taking PERTZYE:
Giving PERTZYE to infants (Children from Birth to 12 Months of Age) by mouth:
The two methods to give PERTZYE to Infants (Children from Birth to 12 Months of Age) are described below:
a) Giving with Applesauce Before Breast or Formula Feeding
b) Giving Directly into the Infant's Mouth Before Breast or Formula Feeding
Do not mix the PERTZYE capsule contents directly into a bottle of breast milk or formula.
Giving PERTZYE to children and adults by mouth:
Giving PERTZYE through a gastrostomy tube:
Figure A |
Figure B |
Figure C |
Figure D |
Storing PERTZYE:
Keep PERTZYE and all medicines out of the reach of children.
Manufactured by:
Digestive Care, Inc.
1120 Win Drive
Bethlehem, PA 18017
U.S. License No. 2184
Product of USA
© 2024 Digestive Care, Inc.
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Revised: 02/2024
100 Capsules
NDC 59767-008-01
pancrelipase
PERTZYE®
Rx Only
Delayed-Release Capsules
DOSE BY
LIPASE
UNITS
Lipase
8,000 USP Units
Protease
28,750 USP Units
Amylase
30,250 USP Units
Each delayed-release capsule contains pancrelipase
in bicarbonate-buffered enteric-coated microspheres.
This product is of porcine origin. No preservative.
PHARMACIST: Dispense the accompanying
Medication Guide to each patient.
100 Capsules
NDC 59767-004-01
pancrelipase
PERTZYE®
Rx Only
Delayed-Release Capsules
DOSE BY
LIPASE
UNITS
Lipase
4,000 USP Units
Protease
14,375 USP Units
Amylase
15,125 USP Units
Each delayed-release capsule contains pancrelipase
in bicarbonate-buffered enteric-coated microspheres.
This product is of porcine origin. No preservative.
PHARMACIST: Dispense the accompanying
Medication Guide to each patient.
100 Capsules
NDC 59767-016-01
pancrelipase
PERTZYE®
Rx Only
Delayed-Release Capsules
DOSE BY
LIPASE
UNITS
Lipase
16,000 USP Units
Protease
57,500 USP Units
Amylase
60,500 USP Units
Each delayed-release capsule contains pancrelipase
in bicarbonate-buffered enteric-coated microspheres.
This product is of porcine origin. No preservative.
PHARMACIST: Dispense the accompanying
Medication Guide to each patient.
80 Capsules
NDC 59767-024-01
pancrelipase
PERTZYE®
Rx Only
Delayed-Release Capsules
DOSE BY
LIPASE
UNITS
Lipase
24,000 USP Units
Protease
86,250 USP Units
Amylase
90,750 USP Units
Each delayed-release capsule contains pancrelipase
in bicarbonate-buffered enteric-coated microspheres.
This product is of porcine origin. No preservative.
PHARMACIST: Dispense the accompanying
Medication Guide to each patient.
PERTZYE
pancrelipase capsule, delayed release |
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PERTZYE
pancrelipase capsule, delayed release |
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PERTZYE
pancrelipase capsule, delayed release |
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PERTZYE
pancrelipase capsule, delayed release |
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Labeler - Digestive Care, Inc. (831065214) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
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Digestive Care, Inc. | 831065214 | manufacture(59767-008, 59767-016, 59767-004, 59767-024) |